BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 19399121 · Received May 26, 2024

    Report

    Report Number
    3006630150-2024-03395
    Event Type
    Injury
    Date Received
    May 26, 2024
    Date of Event
    May 7, 2024
    Report Date
    June 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7083784.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN TOOK MULTIPLE ATTEMPTS TO GET LEADS INTO PLACE BEFORE OBTAINING THE OPTIMAL POSITION. FOLLOWING THE PROCEDURE, THE PATIENT REPORTED INCREASING PAIN DOWN THE LEGS EVEN WHEN STIMULATION WAS OFF. THE PHYSICIAN WAS UNSURE OF THE CAUSE OF PAIN. THE PATIENT WAS PRESCRIBED WITH PAIN MEDICATIONS AND WAS GIVEN INJECTIONS. UPON FOLLOW-UP, THE PATIENT WAS DOING WELL AND HAD FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN TOOK MULTIPLE ATTEMPTS TO GET LEADS INTO PLACE BEFORE OBTAINING THE OPTIMAL POSITION. FOLLOWING THE PROCEDURE, THE PATIENT REPORTED INCREASING PAIN DOWN THE LEGS EVEN WHEN STIMULATION WAS OFF. THE PHYSICIAN WAS UNSURE OF THE CAUSE OF PAIN. THE PATIENT WAS PRESCRIBED WITH PAIN MEDICATIONS AND WAS GIVEN INJECTIONS. UPON FOLLOW-UP, THE PATIENT WAS DOING WELL AND HAD FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PAIN WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305911 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7080819 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention